(60 days)
K153066, P860022/S40
No
The document describes a physical prosthetic device and its materials, with no mention of software, algorithms, or AI/ML technologies.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The BostonSight PD Prosthetic Device for daily wear is also indicated for therapeutic use in eyes with ocular surface disease from dry eye... and corneal exposure..."
No
Explanation: The BostonSight PD Prosthetic Device is described as a prosthetic device for managing distorted corneal surfaces and ocular surface diseases, providing vision correction and therapeutic benefits. It is not used to diagnose conditions.
No
The device description clearly states it is a "prosthetic device for the ocular surface lathe cut from one of the following fluoro-silicone acrylate materials," which are physical materials, not software. The description details its physical design and how it interacts with the eye.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly indicate that the BostonSight PD Prosthetic Device is a physical device placed on the ocular surface (cornea and sclera) of the eye. It does not analyze or test any biological samples taken from the body.
- The function is mechanical and therapeutic. The device works by physically vaulting over the cornea, creating a tear reservoir, and protecting the ocular surface. Its primary functions are to manage corneal distortion and provide therapeutic benefits for ocular surface disease. These are not diagnostic functions.
- The performance studies are based on clinical outcomes and material safety. The studies referenced focus on the safety and effectiveness of the contact lens materials and their clinical performance in patients, not on the accuracy of a diagnostic test.
Therefore, the BostonSight PD Prosthetic Device is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Boston Sight PD Prosthetic Device for daily wear is indicated for the management of a distorted corneal surface that:
-
- precludes satisfactory spectacle lens correction
-
- demonstrates significant improved rigid contact lens corrected vision
-
- is incapable of wearing traditional corneal lenses because of the inability to achieve adequate lens centration/stability and/or tolerance to physical contact with a lens
Causes of corneal distortion include corneal degeneration (e.g. keratoglobus, pellucid marginal degeneration, Salzmann's nodular degeneration), corneal dystrophy (e.g. lattice dystrophy, Reis-Bucklers dystrophy), and scarring from surgery (e.g. corneal transplant, LASIK, radial keratotomy), infection, or trauma.
- is incapable of wearing traditional corneal lenses because of the inability to achieve adequate lens centration/stability and/or tolerance to physical contact with a lens
The BostonSight PD Prosthetic Device for daily wear is also indicated for therapeutic use in eyes with ocular surface disease from dry eye (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome, limbal stem cell deficiency (e.g.Stevens-Johnson syndrome, chemical and thermal burns, radiation), disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex, Herpes zoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment. When prescribed for therapeutic use for distorted cornea or ocular surface disease, the BostonSight PD Prosthetic Device may incidentally provide correction of refractive error.
The BostonSight PD Prosthetic Device may be cleaned and disinfected using a chemical (not heat) care system.
Product codes (comma separated list FDA assigned to the subject device)
HOD
Device Description
The BostonSight PD Prosthetic Device is a daily wear, prosthetic device for the ocular surface lathe cut from one of the following fluoro-silicone acrylate materials:
- · roflufocon D (supplied by Contamac Ltd.)
- · roflufocon E (supplied by Contamac Ltd.)
- · oprifocon A (supplied by Bausch & Lomb, Inc.)
- · hexafocon B (supplied by Bausch & Lomb, Inc.)
The BostonSight PD Prosthetic Device is designed to vault over the cornea and rest on the conjunctiva overlying the sclera, resulting in a tear reservoir between the back surface of the prosthetic device and the corneal surface. The tear reservoir masks optical distortions from an irregular corneal surface, and in combination with the device itself, protects the ocular surface from an adverse external environment, including but not limited to dysfunctional evelids and margins. The design parameters are customized to allow for tear exchange underneath the device.
The BostonSight PD Prosthetic Device may be shipped "dry" or "wet" in a polypropylene contact lens case. The primary container for shipping the BostonSight PD Prosthetic Device is the Bausch & Lomb Frequent Replacement Contact Lens Case, with clearance under 510(k) K896685. When shipped "wet". The BostonSight PD Prosthetic Device manufactured from material supplied by Bausch & Lomb, inc. may be packaged and shipped in Boston Advance Comfort Formula Conditioning Solution (K974466) or Boston SIMPLUS Multi-Action solution (K024289). The BostonSight PD Prosthetic Device manufactured from material supplied by Contamac, Ltd. may be packaged and shipped "wet" in in the OPTIMUM by Lobob Cleaning and Disinfecting Storage solution, with clearance under 510(k) K014162.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ocular surface, cornea, conjunctiva, sclera
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
~ Non-Clinical Studies ~
Non-clinical testing to demonstrate the safety and effectiveness of contact lenses manufactured from roflufocon D, roflufocon E, oprifocon A, and hexafocon B has been addressed by reference to the predicate device, BostonSight IC Corneal & Scleral Lens (K153066).
~ Clinical Studies ~
Clinical testing to demonstrate the safety and effectiveness of contact lenses manufactured from roflufocon D, roflufocon E, oprifocon A, and hexafocon B has been addressed by reference to the following:
- OPTIMUM GP(roflufocon D, roflufocon E) Daily Wear Contact Lenses K033594 ●
- . Boston EQUALENS II (oprifocon A) Rigid Gas Permeable Contact Lenses - K022128
- . Boston XO2 (hexafocon B) Daily Wear Contact Lens - K071266
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K153066, P860022/S40
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 886.5916 Rigid gas permeable contact lens.
(a)
Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping to create a sense of depth and connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 25, 2016
BostonSight % Mr. Bret Andre Principal Consultant EyeReg Consulting, Inc. 6119 Canter Ln. West Linn, OR 97068
Re: K161461
Trade/Device Name: BostonSight PD Prosthetic Device Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HOD Dated: May 20, 2016 Received: May 26, 2016
Dear Mr. Andre:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Denise L. Hampton -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K161461
Device Name BostonSight PD Prosthetic Device
Indications for Use (Describe)
The Boston Sight PD Prosthetic Device for daily wear is indicated for the management of a distorted corneal surface that:
-
- precludes satisfactory spectacle lens correction
-
- demonstrates significant improved rigid contact lens corrected vision
- is incapable of wearing traditional corneal lenses because of the inability to achieve adequate lens centration/stability and/or tolerance to physical contact with a lens
Causes of corneal distortion include corneal degeneration (e.g. keratoglobus, pellucid marginal degeneration, Salzmann's nodular degeneration), corneal dystrophy (e.g. lattice dystrophy, Reis-Bucklers dystrophy), and scarring from surgery (e.g. corneal transplant, LASIK, radial keratotomy), infection, or trauma.
The BostonSight PD Prosthetic Device for daily wear is also indicated for therapeutic use in eyes with ocular surface disease from dry eye (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome, limbal stem cell deficiency (e.g.Stevens-Johnson syndrome, chemical and thermal burns, radiation), disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex, Herpes zoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment. When prescribed for therapeutic use for distorted cornea or ocular surface disease, the BostonSight PD Prosthetic Device may incidentally provide correction of refractive error.
The BostonSight PD Prosthetic Device may be cleaned and disinfected using a chemical (not heat) care system.
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
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4
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K161461 Applicant information: July 22nd, 2016 Date Prepared: Name: BostonSight Address 464 Hillside Avenue, Suite 205 Needham, MA 02494 Contact Person: Gene P. Guselli President and CEO Phone number: 781-726-7337 EyeReg Consulting, Inc. Consultant/Correspondent: Bret Andre Phone number (503) 372-5226 Fax number (503) 419-4475
Device Information:
| Device Classification: | Class II |
|---|---|
| Classification Number: | HQD |
| Classification Name: | Lenses, Rigid Gas Permeable, Daily Wear |
| Trade Name: | BostonSight PD Prosthetic Device |
5
Predicate Devices:
The BostonSight PD Prosthetic Device is substantially equivalent to the following predicate device(s)
- "BostonSight IC Corneal & Scleral Lens" . - Primary Predicate Manufactured by Boston Foundation for Sight 510(k) number; K153066
- "Boston" Scleral (itafluorofocon B) RGP Contact Lens for Daily Wear" . – Reference Predicate Manufactured by Boston Foundation for Sight PMA number: P860022/S40
Device Description:
The BostonSight PD Prosthetic Device is a daily wear, prosthetic device for the ocular surface lathe cut from one of the following fluoro-silicone acrylate materials:
- · roflufocon D (supplied by Contamac Ltd.)
- · roflufocon E (supplied by Contamac Ltd.)
- · oprifocon A (supplied by Bausch & Lomb, Inc.)
- · hexafocon B (supplied by Bausch & Lomb, Inc.)
The BostonSight PD Prosthetic Device is designed to vault over the cornea and rest on the conjunctiva overlying the sclera, resulting in a tear reservoir between the back surface of the prosthetic device and the corneal surface. The tear reservoir masks optical distortions from an irregular corneal surface, and in combination with the device itself, protects the ocular surface from an adverse external environment, including but not limited to dysfunctional evelids and margins. The design parameters are customized to allow for tear exchange underneath the device.
The BostonSight PD Prosthetic Device may be shipped "dry" or "wet" in a polypropylene contact lens case. The primary container for shipping the BostonSight PD Prosthetic Device is the Bausch & Lomb Frequent Replacement Contact Lens Case, with clearance under 510(k) K896685. When shipped "wet". The BostonSight PD Prosthetic Device manufactured from material supplied by Bausch & Lomb, inc. may be packaged and shipped in Boston Advance Comfort Formula Conditioning Solution (K974466) or Boston SIMPLUS Multi-Action solution (K024289). The BostonSight PD Prosthetic Device manufactured from material supplied by Contamac, Ltd. may be packaged and shipped "wet" in in the OPTIMUM by Lobob Cleaning and Disinfecting Storage solution, with clearance under 510(k) K014162.
6
| ROFLUFOCON D | ROFLUFOCON E | OPRIFOCON A | HEXAFOCON B | |
|---|---|---|---|---|
| Refractive Index | 1.4333 | 1.4332 | 1.4230 | 1.4240 |
| Light Transmission | ||||
| (clear) | >97% | >97% | >95% | >95% |
| Light Transmission | ||||
| (tinted) | >90% | >90% | >90% | >83% |
| Water Content | 98% UVB |
95% UVA | >98% UVB
95% UVA | >95% UVB
97% UVA | >95% UVB
97% UVA |
The physical properties of the BostonSight PD Prosthetic Device manufactured from the various materials are as follows:
The parameters for the BostonSight PD Prosthetic Device are as follows:
- ન્ન્સ Chord Diameter:
- 米 Center Thickness:
- 米 Base Curve:
- 米 Spherical Powers:
18.0 mm to 26.0 mm 0.05mm to 0.60 mm 5.0 mm to 9.0 mm -25.00 Diopters to +35.00 Diopters
Indication for Use:
The Boston Sight PD Prosthetic Device for daily wear is indicated for therapeutic use for the management of a distorted corneal surface that:
-
- precludes satisfactory spectacle lens correction
-
- demonstrates significant improved rigid contact lens corrected vision
-
- is incapable of wearing traditional corneal lenses because of the inability to achieve adequate lens centration/stability and/or tolerance to physical contact with a lens
Causes of corneal distortion include corneal degeneration (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's nodular degeneration), corneal dystrophy (e.g, lattice dystrophy, Reis-Bucklers dystrophy), and scarring from surgery (e.g. corneal transplant, LASIK, radial keratotomy), infection, or trauma.
7
The BostonSight PD Prosthetic Device for daily wear is also indicated for therapeutic use in eyes with ocular surface disease from dry eye (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome, dry eye syndrome), limbal stem cell deficiency (e.g.Stevens-Johnson syndrome, chemical and thermal burns, radiation), disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex, Herpes zoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment. When prescribed for therapeutic use for distorted cornea or ocular surface disease, the BostonSight PD Prosthetic Device may incidentally provide correction of refractive error.
The BostonSight PD Prosthetic Device may be cleaned and disinfected using a chemical (not heat) care system.
Description of Safety:
- ~ Non-Clinical Studies ~
Non-clinical testing to demonstrate the safety and effectiveness of contact lenses manufactured from roflufocon D, roflufocon E, oprifocon A, and hexafocon B has been addressed by reference to the predicate device, BostonSight IC Corneal & Scleral Lens (K153066).
~ Clinical Studies ~
Clinical testing to demonstrate the safety and effectiveness of contact lenses manufactured from roflufocon D, roflufocon E, oprifocon A, and hexafocon B has been addressed by reference to the following:
- OPTIMUM GP(roflufocon D, roflufocon E) Daily Wear Contact Lenses K033594 ●
- . Boston EQUALENS II (oprifocon A) Rigid Gas Permeable Contact Lenses - K022128
- . Boston XO2 (hexafocon B) Daily Wear Contact Lens - K071266
Substantial Equivalence:
The BostonSight PD Prosthetic Device is substantially equivalent to the Boston" Scleral (itafluorofocon B) RGP Contact Lens for Daily Wear (predicate device) in the following key areas:
- · Device Design
- · Therapeutic indications for use
The BostonSight PD Prosthetic Device is substantially equivalent to the BostonSight IC Corneal & Scleral Lens (predicate device) in the following key areas:
- Components/Materials/Formulation
- · Manufacturing Process
- Manufacturing Facility
- Final Packaging & Wet Shipping
8
The BostonSight PD Prosthetic Device is substantially equivalent to the predicate device as depicted in the following table, and does not raise different questions of safety and effectiveness than the predicate device identified previously.
The following table depicts the pre-clinical characteristics of the BostonSight PD Prosthetic Device, as well as the predicate device(s).
| | BostonSight PD Prosthetic
Device
Subject Device | BostonSight IC Corneal
& Scleral Lens
(K153066)
Predicate Device | Boston® Scleral
(itafluorofocon B)
RGP Contact Lens
(P860022/S40)
Predicate Device |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | Indicated for therapeutic use in eyes with
ocular surface disease from dry eye (e.g.
ocular Graft-versus-Host disease,
Sjögren's syndrome, dry eye syndrome),
limbal stem cell deficiency (e.g.Stevens-
Johnson syndrome, chemical and thermal
burns, radiation), disorders of the skin
(e.g. atopy, ectodermal dysplasia),
neurotrophic keratitis (e.g. Herpes
simplex, Herpes zoster, Familial
Dysautonomia), and corneal exposure
(e.g. anatomic, paralytic) that might
benefit from the presence of an expanded
tear reservoir and protection against an
adverse environment. When prescribed
for therapeutic use for distorted cornea or
ocular surface disease, the BostonSight
PD Prosthetic Device may incidentally
provide correction of refractive error. | Indicated for the correction of
refractive error in aphakic and not
aphakic persons. The lenses may
be prescribed in otherwise non-
diseased eyes that require a rigid
gas permeable lens for the
management of irregular corneal
conditions such as keratoconus,
pellucid marginal degeneration or
following penetrating keratoplasty
or refractive (e.g. LASIK)
surgery. | Indicated for eyes having
significantly reduced vision
due to the presence of a
distorted corneal surface that:
- precludes satisfactory
spectacle lens correction 2)
demonstrates significantly
improved rigid contact lens
corrected vision 3) is
incapable of wearing
traditional corneal lenses
because of the inability to
achieve adequate lens
centration/stability and/or
tolerance to physical contact
with a lens. Furthermore,
eyes suffering from certain
ocular surface disorders may
benefit from the physical
protection and the saline bath
provided by a scleral lens. |
| Device and
Classification | Class II
Lenses, Rigid Gas Permeable, Daily
Wear
HQD | Class II
Lenses, Rigid Gas Permeable,
Daily Wear
HQD | Class II
Lenses, Rigid Gas
Permeable, Daily Wear
HQD
(reclassified from Class II
to Class II in 1994) |
| Production Method | Lathe-cut | Lathe-cut | Lathe-cut |
| FDA Group # | Group # 3 Fluoro Silicone Acrylate | Group # 3 Fluoro Silicone
Acrylate | Group # 3 Fluoro Silicone
Acrylate |
| Water Content |